Skin Marking Tool for Radiological Imaging Material

ABSTRACT

A marking tool for use in the context of radiological and other medical imaging is disclosed. The product is a marking tool for distributing an imaging material onto a patient&#39;s skin to mark that part of the patient&#39;s body for imaging. The imaging technician then knows the area of medical interest, such as an internal injury, and can image that area more accurately. The imaging material shows up on a resulting medical image such as an X-Ray, CT Scan, or MRI to direct a radiology professional to the most important area on the image for diagnostic purposes.

FIELD OF THE INVENTION

The invention relates to the field of radiology and includes tools formarking a patient's skin with an imaging material that is radiopaque or,depending upon the type of radiology, otherwise suitable to be visibleon the image. The imaging material shows up as a visible indicator onboth the patient's skin and the medical image associated with that areaof the patient's body. The marking tool assists radiology professionalsin achieving the highest quality medical image and in analyzing theimage for proper diagnosis.

BACKGROUND OF THE INVENTION

One of the biggest hurdles for a radiologist is the volume of imagesthat must be analyzed every day for diagnostic purposes. Often, theseimages are collected from remote locations, such as individualphysicians' offices or emergency centers. Medical professionals transmitthe images to a central radiology unit where trained professionals“read” the image to determine the next course of action for treatment.Radiology professionals face the task of analyzing hundreds of imagesper day and providing a diagnosis for every patient in a timely manner.This pressure is compounded by the fact that the person reading theimage may have no personal communication with the individual patient orwith the person who actually performed the imaging. In some cases, theimaging specialist or attending physician sends a note with a briefexplanation of the injury being imaged. Often, however, these notes areinsufficient to give the radiologist reading the image a clear focus ofthe exact problem to look for on the multitude of images associated witha patient or group of patients.

As a result, the radiology professional's job is of an extremely broadscope, including the review of many different types of images andparticular areas on those images. With better information regarding theactual area of medical interest on an image, the radiologist could focusthe review to the most pertinent areas.

There is a need in the radiological arts, therefore, for a product thatmarks a patient's body to point out the most pertinent area on acorresponding radiological image.

Prior efforts to meet this need have included various attempts to addpointers to medical images. For instance, some imaging professionalsplace a foreign object on the patient during the scan to emphasize anarea of interest to the person reading the image. Unfortunately, foreignobjects also bring forth the possibility of obscuring a view of themedical problem on the image. Similarly, various directional arrows aresometimes placed on the image to direct the radiologist to a particularregion on the scan. Unfortunately, these can be dislodged inadvertently,pointing to the entirely wrong area.

Still, however, with medical imaging taking on such high tech featuresas 3-D imaging and higher resolution scanning at various angles, effortsto incorporate directional arrows on an image do not meet the true needsof the radiologist.

Other efforts at marking a radiological image have been set forth in thepatent literature and are summarized below.

U.S. Pat. No. 4,813,062 (Gilpatrick '062)

The Gilpatrick '062 patent describes a crayon-like marker composed ofsubstances that are detectable by X-ray examination. Specifically,Gilpatrick discloses a crayon or marking pencil containing a radiopaquesubstance uniformly dispersed within a waxy medium (e.g., paraffin wax)that is used as a tool for applying a mark to an object for inspection.

The Gilpatrick '062 method for applying a radiopaque marker does not,however, disclose the use of such a device to indicate areas of intereston a medical patient. The stated use of the Gilpatrick device and methodis to place a radiopaque mark on a substrate. Specifically, theradiopaque marker is intended for use in the context of textileinspection. Accordingly, Gilpatrick fails to disclose a method for usinga radiopaque marker tool in a medical imaging process.

Because the Gilpatrick device is intended for use in textileexamination, possible detrimental effects of human contact with certainradiopaque compositions may not have been considered by Gilpatrick. Thislack of consideration is evidenced by the fact that the marker disclosedin the '062 patent focuses on compositions containing heavy metals(e.g., bismuth, lead), which in some forms can be toxic to humans.

U.S. Pat. No. 2,462,018 (Wood '018)

The Wood '018 patent also discloses a marker containing a material thatis detectable by X-ray examination. Specifically, Wood discloses acrayon or pencil containing fine particles of radiopaque metal atoms ina carrier or vehicle material, such as a wax. Wood alternativelydiscloses the use of a brush or pen for applying a radiopaque substancein a liquid carrier. The marking device may then be used to apply anX-ray observable mark on the object to be inspected.

Like the Gilpatrick '062 patent, however, the Wood '018 patent disclosesa number of heavy metals (e.g., lead, bismuth, uranium, thallium) as theappropriate radiopaque substances. In fact, Wood specifically focuses onlead and limits the list of appropriate materials to elements having anatomic weight of at least 184, which is even greater than the acceptablerange noted by Gilpatrick. Thus, Wood likewise fails to disclose aradiopaque marker that is designed to be safe for use on medicalpatients.

Unlike Gilpatrick, however, the Wood '018 marker is disclosed for use inanatomical X-ray work. The disclosure of the use of the X-ray marker ina medical context is very limited, and appears that the use of the WoodX-ray marker is intended more for marking the plate or film foridentification purposes than to mark the patient to pinpoint the site ofinjury.

U.S. Pat. No. 4,506,676 (Duska '676)

The Duska '676 patent describes a radiopaque identifier for identifyingthe location of concern on a medical patient so that the examiningphysician can communicate to an X-ray technician or diagnosingradiologist the area on a radiograph to be analyzed. Specifically, Duskadiscloses a tape provided with a series of radiopaque markings forming adashed line along the center of the tape. The radiopaque materialdisclosed is barium sulfate, but Duska also notes that other pigments orpowdered or finely divided material known to be opaque to X-radiationmay also be appropriate. Accordingly, Duska discloses the use of saferadiopaque substances applied to a medical patient to identify thelocation of interest in medical imaging.

Duska does not, however, disclose any tool that applies the radiopaquesubstance directly to a patient's skin. The patent's disclosure islimited to a tape having radiopaque markings, so the examining physicianis limited in the types of marks that can be made by the shape of thetape. Thus, although Duska discloses a radiopaque marking device andsystem that allows an examining physician to communicate the area ofinterest to later parties examining the resulting X-ray, the '676 patentfails to provide a better way to mark the skin in a visible manner sothat the image is taken of the correct spot and the resulting picture ismarked for diagnosing that spot.

U.S. Pat. No. 5,193,106 (DeSena '106)

The DeSena '106 patent describes a device for marking landmarks on theskin as a means of identifying areas of interest under x-radiography.The device involves a radiopaque material affixed to an adhesive tape.The radiopaque material may be formed into a variety of shapes, such asa circle, triangle, or square to provide a marker that encircles thepoint of interest. The markers are pre-cut and affixed to a roll of tapeand distributed from a dispenser, so the markers can be easilydispensed.

DeSena does not disclose a pencil, pen, marker, or any other tool thatapplies the radiopaque substance, though. Further, the DeSena markersare limited in size and shape to the preformed stickers. In fact, DeSenanotes that the markers disclosed are different from prior markers inthat they are specifically designed to identify small areas.Accordingly, the examining physician is limited in the markings that canbe made and may be especially limited if a relatively large area is thearea to be analyzed. Thus, although DeSena discloses another form ofradiopaque marker, the '106 patent likewise fails to disclose each andevery element of the current invention

This review of the pertinent art shows that none of the publishedmaterial or known products on the market fully address the radiologists'problems of image placement during the patient scanning process or imagemarking to focus the radiologists' review. The invention herein is,therefore, an important advancement over all prior work in the relatedfields.

BRIEF SUMMARY OF THE INVENTION

The invention is a tool and an associated method of distributing aradiopaque material directly onto the skin of a patient in a medicalenvironment to highlight an area of medical interest on a radiologicalimage. The radiopaque material is visible on the patient's skin toassist medical personnel in taking an image of the most useful area fordiagnosis. Accordingly, the radiological image shows an area of apatient's body with an opaque marker highlighting the most useful partof the image for diagnosis. The radiopaque material shows up on theimage but does not block the view of an underlying internal conditionthat the patient is experiencing.

In other embodiments, the invention is a tool for distributing theradiopaque material onto the patient's skin. The distribution toolsdescribed herein are compact, portable, and useful for more than oneapplication to different patients while maintaining sterility andappropriate hygienic standards. Without limiting the scope of theinvention in any way, the tools disclosed herein include technology forswabbing the radiopaque material onto the patient with a disposableapplicator, stamping the radiopaque material onto the patient's skin,and drawing on the patient's skin with radiopaque media via anapplicator.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a marking tool for applying imaging material directly onto apatient's skin via a swab tip.

FIG. 1B is an embodiment of FIG. 1A in which the radiopaque imagingsolution is housed in a breakable vial within the marking tool of FIG.1A.

FIG. 2 is a marking tool for applying imaging material directly onto apatient's skin via a squeezable dispenser that does not touch thepatient.

FIG. 3 is a marking tool having a dispensing tip that is pre-soaked withimaging material and stored in a dispenser.

FIG. 4 is a marking tool as in FIG. 3 in which the dispenser has acontrolling side-button for pushing out the next marking tool from thedispenser.

FIG. 5A is a marking tool for stamping an imaging material directly ontoa patient's skin in a certain pattern for use by a radiologist.

FIG. 5B is a bottom view of the marking tool of FIG. 4 a showing oneassociated stamp pattern in the form of a grid.

FIG. 5C is a bottom view of a marking tool in the form of a stamp thatforms a ruler image on a patient's skin.

FIG. 5D is a bottom view of a marking tool in the form of a stamp thatforms a target image using concentric circles and radiating sectors.

FIG. 6A is a cross-sectional view of an imaging material dispenser inwhich stamping designs are reeled on winding tape and soaked in imagingmaterial during use.

FIG. 6B is a cross-sectional view of an imaging material dispenser inwhich stamping designs are reeled on winding tape soaked in solution andtorn off for discarding.

FIG. 7A is a plan view of an imaging material dispenser havingpre-soaked wicks with imaging material reservoirs in the dispensing headattached to a handle.

FIG. 7B is a side view of the imaging material dispensing head accordingto FIG. 7A.

FIG. 7C is a plan view of a cartridge for holding and dispersingmultiple imaging material dispensing heads shown in FIGS. 7A and 7B.

DETAILED DESCRIPTION

The invention is a device and method for marking a patient's body with asuitable substance to identify a location of medical interest, such asthe site of a patient's injury. The marking substance, or imagingmaterial, is selected to show up on medical images associated with thatpatient so that a radiologist or clinician evaluating the images caneasily determine the exact site of medical interest. The imagingmaterial further marks the patient's skin to assist the person preparingthe image in the first place.

The invention is intended to be used in any setting where medical imagesare used for diagnosis. Accordingly, the term “medical image” is used inits broadest sense and includes, but is not limited to X-rays, CT scans,fluoroscopy, and MRI technology.

The invention includes the use of specialized substances, referred toherein as “imaging materials” that show up on a medical image to markthe area of medical interest without obscuring the view of importantfeatures. The imaging material may be contained in a dispenser capableof placing a small, quick-drying mark on the patient. In a preferredembodiment, the imaging material is visible on the patient's skin toassist the person preparing the patient for imaging in identifying theoptimal location. The imaging material has a sufficient concentration tobe visible to medical imaging devices (e.g., appears on x-ray films, CTscans, and MRIs), and yet it is not so dense that it obscures the image.

The imaging material is selected based on the type of medical imagingused. For example, compositions containing barium or iodine are suitablefor radiographic imaging (i.e., x-ray); dilute iodine-based substancesmay be appropriate for use with computed tomography (CT); oil basedsubstances, such as Vitamin E or flax seed oil mixtures, and gadoliniumcompositions are used for magnetic resonance imaging (MRI). In generalterms, the imaging material incorporates a substance for highlighting anexamination area on both a patient's skin and an associated radiologicalimage. The radiological images include, without limitation, CT scans,MRI, X-ray, and fluoroscopy technology. The invention incorporates theuse of any material that is safe for application directly onto apatient's skin and that will show up as a marker on an associatedradiological image. Regardless of the application, the imaging materialused in this context is safe for skin contact.

The imaging material may be selected from a variety of colorsappropriate for the patient's skin tone, the radiologists' goals inproviding certain information on the skin, and the availability ofparticular pigments for the desired application. In the most preferredembodiment, the imaging material should be of a color, consistency, anddensity that allows the material to dry onto the skin quickly withoutrunning or smearing. The imaging material should further be of theappropriate density to show up on a medical image as a marker withoutcompletely obscuring the view of the underlying area of medical interestwithin the patient's body. The imaging materials described hereininclude versions that are appropriately diluted for use in anyparticular situation.

The substance may be applied as a liquid or paste dispensed from adevice that is convenient to use in a medical setting. The device, ormarking tool, may take any form that produces a quick-drying mark thatmay be quickly and easily placed on the patient without causing anydiscomfort. In a preferred embodiment of this invention, the markingtool applies the imaging material directly to the patient's skin priorto completing the imaging.

The marking tool (10) may be in the form set forth in the attachedfigures and the following claims. In a first embodiment, the markingtool (10) includes a substantially hollow vessel (15) for holding theimaging material (13). The marking tools of this invention include a tip(17) at one end of the hollow vessel (15) to define an opening to theinterior of the vessel (15) for controlled distribution of the imagingmaterial (13). By using the marking tool (10), a radiology professionalcan apply an imaging material (13) for distribution through the tip (17)directly onto the patient's skin to mark the examination area.

FIG. 1 shows a more preferred embodiment of the marking tool (10)disclosed herein. In FIG. 1, a marking tool (10) again includes asubstantially hollow vessel (15) defining an opening at a first end(20). The marking tool is adapted for distributing imaging material (13)directly onto a patient's skin through a distribution tip (17) fittingwithin the opening of the hollow vessel (15). The tip (17) is in fluidcommunication with the interior of the hollow vessel (15) for controlleddistribution of the imaging material (13) onto the patient. A closedchamber (25) within the vessel (15) extends from a second end (21) ofthe substantially hollow vessel (15) toward the opening at the first end(20), and an imaging material (13) is retained within the closed chamber(25).

As shown in FIG. 1B, the hollow vessel (15) is pliable for bending, andthe closed chamber (25) is breakable upon bending the hollow vessel(15). When the closed chamber (25) breaks, the imaging material (13) isreleased and flows through the tip (17) of the marking tool (10) fordirect dispersion onto a patient's skin.

In a most preferred embodiment of the device of FIG. 1, the tip (17)incorporates applicator (30) (e.g., a swab or wick) that absorbs theimaging material (13) and becomes soaked with imaging material (13) formore comfortable distribution onto the skin. After the imaging material(13) is applied to the skin, the marking tool (10) of FIG. 1 can simplybe discarded.

One useful feature of the marking tool (10) is that it is adapted foruse with imaging materials (13) that dry or otherwise stay on the skinso that an imaging technician can use the mark to ensure more accuratescanning. Furthermore, the imaging material (13) shows up on the image(usually an X-ray, CT scan, or MRI) for diagnosis by another medicalprofessional. The image on the scan pinpoints areas of medical inquiryto allow a radiologist to focus the review on the most critical areaswithin an image.

In a different embodiment of FIG. 1, the closed chamber (25) may also beconfigured to release the imaging material into the hollow vessel bybending both the hollow vessel (15) and the closed chamber (25). In thisembodiment, the chamber (25) does not break to release imaging material(13) into the hollow vessel. Instead, the chamber may include a puncturevalve at one end. The term “puncture valve” includes, but is not limitedto, any hole in the chamber that retains a normally closed(“self-sealed”) position, but will allow the imaging material (13) toescape through the hole if the chamber is squeezed or bent. The puncturevalve is essentially a hole in the chamber (25) made of a pliablematerial, e.g., a rubber or other synthetic material, that closes upunless the imaging material (13) exerts enough pressure on the wall ofthe chamber (25) to force the hole into an opened position. When thepressure from squeezing or bending the chamber (25) is reduced, thematerial forming the chamber closes upon itself and seals the hole sothat no additional imaging material (13) escapes. In this embodiment,the chamber (25) releases the imaging material into the hollow vessel(15), allowing the imaging material (13) to be dispensed through the tip(17) of the marking tool (10), preferably through a swab or wick (30)attached to the tip (17) of the marking tool (10).

FIG. 2 is another representation of the radiological marking tool (35)of this invention. Again, the tool (35) includes a hollow vessel (40)that may either contain the imaging material (13) itself, or it maycontain the separate chamber (50) described above for holding theimaging material (13) until dispersion.

Using a separate chamber (25, 50) in any embodiment of this inventionmay be generally preferred for better control over distribution or forallowing a marking tool (10, 35) to be re-used by simply incorporating anew chamber (25, 50) full of imaging material (13) when the priorchamber runs dry.

As shown in FIG. 2, the hollow vessel (40) of this product may include adistribution tip (42) for marking the patient with imaging material(13). The distribution tip (42) may be a permanently attached article,similar to a highlighter tip, or the distribution tip may be a removableapparatus that would be discarded after a single use on a patient.

Using a removable, disposable tip (42) on the marking tool (35) of FIG.2 is one preferred embodiment that is useful to prevent contaminationbetween uses on different patients. To further ensure that any germs orcontamination on the tip (42) does not backflow into the hollow vessel(40) of imaging material (13), the instrument of FIG. 2 could use aseparate chamber (50) of imaging material (13) inside the hollow vessel(40). Any one of the previously described mechanisms for releasing theimaging material (13) into the hollow vessel (40) would work in thedevice of FIG. 2. In other words, the chamber (50) in the FIG. 2 markingtool (35) could incorporate the puncture valve or a breakable chamberthat floods the hollow vessel (40).

Various embodiments of the removable, replaceable tip (42) are alsoavailable for use in this embodiment. In the examples of FIG. 1, thedistribution tip (42) is of a conical shape for controlling the amountof imaging material that flows out of the hollow vessel (40) onto thepatient. For example, the removable tip (42) could be in the form of anipple that distributes the imaging material (13) upon squeezing orapplying pressure. The nipple would be formed of an elastic type ofmaterial that is temporarily deformable but pops back into shape.

In a different embodiment of FIG. 2, the chamber (50) may be separatedfrom the tip (42) by a valve assembly that opens and closes by turning.For example, by turning the distribution tip (42) in one direction, anormally closed rotating valve may open, allowing the imaging materialto flow into the distribution tip. After filling the tip (42), the usercloses the rotating valve back so that only the imaging material in thetip ever comes near the patient's skin. The valve assembly, therefore,prevents back flow contamination from the patient's skin from corruptingthe sterility of the imaging material in the chamber (50).

If the chamber (50) incorporated into the device of FIG. 2 uses apuncture valve to control imaging material flow, then the hollow vessel(40) could be configured as a pliable or flexible material that can besqueezed to exert pressure onto the chamber (50).

FIG. 2 is a good example of using squeezable hollow vessels (40) todistribute the imaging material (13). In FIG. 2, the imaging material(13) resides in the bottle-shaped vessel (40) and is easily distributedthrough a hole in the tip (42). The imaging technician squirts theimaging material directly onto a patient's skin without touching thepatient. This distribution method is useful in applications for which awide distribution of imaging material is sufficient or applications inwhich just one dot of imaging material will suffice. The hollow vessel(40) of FIG. 2 is sufficiently resilient to resist deformation afterbeing subject to compressive force.

The vessels that house and distribute the imaging material of thisinvention are in no way limited by the figures and discussions above.The vessel can take the shape of any container capable of distributingthe imaging material (13), including but not limited to vessels thatsquirt or spray the imaging material directly onto the patient. Forvessels that spray the imaging material, the invention encompasses allperipheral devices such as straws or nozzles that direct the spray in adesired manner. The vessel, then, includes embodiments such as aerosolcontainers or pump action bottles configured for the application athand.

FIG. 3 and FIG. 4 show embodiments of the marking tool that arecompletely disposable after a single use. The marking tool (55) includesa multi-faceted grip (57) attached to a body (58) that holds a wick (60)for distributing the imaging material (13) onto the patient. The grip(57) defines a cavity (62) in which the wick (66) of another markingtool (65) may slide in a nesting configuration. When nested, the wick(66) of one marking tool (65) slides into the cavity (62) of an adjacentgrip (57) so that the bodies (58, 68) of at least two marking tools (55,65) align and connect. In a preferred embodiment, the wicks (60, 66) ofeach marking tool (55, 65) may be surrounded by a respective sealing cap(61, 59). The sealing cap (61, 59) may be sized to fit within the cavityof an adjacent grip (57) for a secure nesting configuration.

The sealing cap (61, 67) on each wick (60, 66) in FIG. 3 allows for thewicks to be pre-soaked in imaging material (13) for application onto apatient. The pre-soaked wicks (60, 66) maintain their moistness anddistribution capabilities because the sealing cap (61) is sufficientlyimpermeable to prevent evaporation of the imaging material (13). Toensure that each wick (60, 66) is sufficiently soaked with imagingmaterial (13) upon use, the product may include reservoirs (72, 73) ofimaging material (13) within the body (58, 68) of the marking tool (55,65). The wicks (60, 66) then have the reservoir (72, 73) to replenishimaging material (13) that has evaporated due to storage conditions.

The nesting feature of the marking tools (55, 65) shown in FIG. 3 makesthe marking tools (55, 65) compatible with a dispenser (80). Thedispenser (80) includes a spring (83) that engages the body (56) of afirst marking tool (54). The spring (83) is connected to the dispenser(80) and biased to push the nested marking tools (54, 55, 65) outwardtoward an opposite end (87) of the dispenser (80). At the end (87) ofthe dispenser (80) opposite the spring (83), the dispenser includes aretention lip (89) that engages the body (68) of a marking tool (65) tobe dispensed out of the opposite end (87). The retention lip (89) may bemade of a flexible material, such as a rubber or other compositesubstance, that is sufficiently stiff to retain the nested marking tools(54, 55, 65) within the dispenser (80) even in light of the oppositeforce of the spring (83).

In the dispenser (80), the retention lip (89) engages the body (68) ofthe marking tool (65) that is in line for dispensing next. The body(68), therefore, includes the grip (67) with ridges (102) that passthrough the retention lip (89). The body (68) of the marking tool (65),however, engages the retention lip (89) and rests against the lip (89).In this embodiment, the body (68) of the marking tool (65) includes aprotrusion (104) that is sufficiently wide for the retention lip (89) tohold the body (68) back. As shown in FIG. 3, at this point, the grip(67) pushes past the retention lip (89) and is available for manualremoval. The remainder of the body (68) remains on the opposite side ofthe retention lip (89) within the dispenser (80). A dispenser cap (86)is available to close off the marking tools from the outside elements,further protecting the individual wicks (60, 66) from evaporation.

In use, then, the dispenser of FIG. 3 allows a radiology professional toremove the dispenser cap (86), manually pull the grip (67) of themarking tool (65) up for dispensing, and remove the body (68) of themarking tool (65) past the retention lip (89). The marking tool (65) isthen retrieved from the nested series of marking tools in the dispenser(80). In one embodiment, the retrieved marking tool is removed with itswick sealing cap (106) remaining in the grip cavity of the immediatelyadjacent marking tool. In other embodiments, the entire marking tool,including the sealing cap (106) is removed, and the radiologyprofessional removes the wick sealing cap for disposal. The dispenser(80) may be of any size and shape that is useful to dispensing themarking tools. For example, and without limiting the invention, thedispenser (80) may be shaped similarly to a pen and conveniently fitinside the user's jacket or shirt pocket. For this embodiment, thedispenser (80) includes a pocket clip (82) for ease of retrieval. Themarking tool of FIG. 3 incorporates a removable loading cap (88)attached to the spring (83). The user can unscrew the removable loadingcap (88), pull out the spring, and insert more nested marking toolstherein.

The embodiment of FIG. 4 includes all of the above discussed elementsfrom FIG. 3 with the addition of a side button (110) for pushing themarking tools (55, 65, 95) through the retention lip (89). As noted inregard to FIG. 3, the body (98) of the marking tool (95) has aprotrusion (104) that engages the retention lip (89) and prevents thespring (83) from pushing the marking tool (95) out the opposite end(87). In the embodiment of FIG. 4, the dispenser (80) is equipped with aside button (110) that includes an exterior component (115) that slidesalong a rail (117). The side button further includes an interiorcomponent (116) in the form of an edge (119) that engages the protrusion(104) of a marking tool (95). The side button (110) engages a recoilspring (120) that is biased to expand in the opposite direction as thedispenser spring (83). The user manually pushes the side button (110) inthe direction of the arrow shown in FIG. 4 to push one of the markingtools (95) out of the dispenser (80). The recoil spring (120) pulls theside button (110) back away from the dispensing, or opposite end (87).The nested marking tools move in response to the spring (83) and therecently dispensed marking tool removal such that the protrusion (104)on the body (98) of a marking tool closer to the spring (83) is forcedover the interior component, or edge (116, 119), of the side button. Inthis way, the series of nested marking tools advance down toward thedispensing end (87) of the dispenser (80) in an orderly and controlledway.

The embodiments depicted in FIGS. 3 and 4 are useful in the way thateach marking tool (55, 65, 95) is dispensed individually for single useand disposal. The spring (83) end of the dispenser also may include aloading cap (85) that is removable, such as a screw cap. The loading capand spring assembly can be removed, allowing for reloading the dispenserwith additional marking tools.

The next embodiment of the marking tool according to this invention isshown in FIGS. 5A and 5B. In this embodiment, the marking tool (200)includes the hollow vessel (204) and closed chamber (208) embodimentdiscussed above. In addition, however, the marking tool (200) includes amechanism for moistening a stamp pad (210) in fluid communication withthe imaging material (13) released from the chamber (208) or the hollowvessel (204). The stamp pad may include numerous designs as shown inFIGS. 5B, 5C, and 5D.

In the embodiment of FIG. 5A, the marking tool (200) has capillaries(209) that moisten multiple regions of a stamp pad (210). Otherembodiments may not require such extensively controlled imaging materialflow, and the capillaries may be replaced with any conduit for movingthe imaging material from the hollow vessel to an attached stamp pad.

In using the marking tool (200) of FIG. 5A, the radiology professionalsoaks an attached stamp pad (210) with imaging material housed in thehollow vessel (204). The soaking step may be accomplished in many ways,including breaking a closed chamber (208) of imaging material within thehollow vessel (204) or squeezing the hollow vessel (204) to release theimaging material (13) onto the stamp pad (210). In the drawing of FIG.5A, the user would squeeze the hollow vessel (204) to push the imagingmaterial (13) through the capillaries (209) onto an attached stamp pad(210). Once the stamp pad is sufficiently moistened with imagingmaterial, the user would stamp a design of imaging material onto thepatient's skin. To accomplish the desired marking, the stamp pad (210)includes moistened raised ridges (211) that have been flooded withimaging material and release that imaging material upon contact with theskin. As shown in FIG. 5A, the capillaries direct the imaging materialto the raised, or patterned, portions of the stamp pad (210).

The marking tool of FIG. 5A may be a one-time use instrument, but theproduct encompasses those marking tools that have replaceable stampingpads on the bottom of the marking tool. In one embodiment, the stampingpads are attached as a peeling stack in which each used stamping pad isremoved individually after use. To ensure sterility of use, the stampingpad may be formed in a stack in which each individual pad is peeled offfrom the adjacent pad, leaving behind a release layer that ensures thatthe remaining pad is sterile.

The patterns are in no way limited to any one design. Useful designsinclude, but are not limited to, grids as shown in FIG. 5B. These gridsare helpful to a radiologist conducting a CT-guided biopsy in which theimaging material shows up on the image as well as the patient's skin.The radiologist evaluates the internal position of a mass to bebiopsied, the design of imaging material distributed onto the skin, andthe position of that design in relation to the mass on the patient'smedical image. The radiologist then directs the needle or other medicalinstrument to the most accurate location for treatment. The inventionfurther encompasses a stamp, such as that of FIG. 5C, that prepares anexamination area with marked measurements. In a separate embodiment, theimaging material can form a tattoo-like ruler on the patient's skin sothat the radiologist can determine distances in certain diagnosticenvironments, such as angiographic procedures, with more accuracy. FIG.5D is a useful design for breast tissue biopsies in which a circulartarget type of design is divided into sectors formed from radiatingsegments.

FIGS. 6A and 6B include yet another embodiment of a marking tool (300)according to this product for dispensing imaging material (13) onto thepatient. In regard to FIG. 6A, a desirable stamping design is formedonto a patterned tape (302) in which the pattern is formed of absorptivematerial that readily soaks with imaging material (13). The tape (302)may include any useful and desirable pattern in the form of raisedridges (303) on the tape (302). The ridges (303) are particularly spongyand absorptive to imaging material (13) while the portions of the tapebetween the ridges (303) is less absorptive or not absorptive to imagingmaterial at all. In this embodiment, the ridges (303) are designed toabsorb imaging material onto the patterned part of the tape (302) andrelease the imaging material (13) when the ridges (303) are squeezedagainst a patient's skin.

In one embodiment, the marking tool of FIG. 6A includes a stamping body(318) that is substantially firm to press against the patient's skin.The stamping body (318) defines multiple cavities in which operationalparts of the marking tool fit. A first cavity (320) houses an imagingmaterial reservoir (325) that is in fluid communication with a sponge(328). The reservoir (325) of imaging material (13) maintains the spongein a saturated state. A second cavity (321) within the stamping bodyhouses a dispensing rolling bar (310). In this embodiment, the tape(302) is formed into a concentrically wound roll (301) that can beattached to the dispensing roller bar (310) within the marking tool(300). The dispensing roller bar (310) is positioned within the secondcavity (321) defined by the stamping body (318) of the marking tool(300). The stamping body (318) further defines a third cavity (322) inwhich a take-up roller bar (311) allows for used portions of thepatterned tape (302) to wind up after use. The cavities (320, 321, 322)are accessible for replenishing the imaging material (13), the reservoir(325), the sponge (328), or the patterned tape (302). The roller bars(310, 311), can be wound with handles (not shown) or even automated takeup gears.

In operation, the marking tool (300) is useful for pressing the stampingbody (318) onto the patient's skin with the patterned tape (302) betweenthe stamping body and the skin. In this way, the ridges (303) on thepatterned tape (302) release the imaging material (13) absorbed thereinand form a pattern of imaging material (13) onto the patient. Again, thepattern of imaging material is visible to the technologist setting upand operating the imaging machinery. The imaging material (13) patternalso shows up on the associated medical image without obscuring theunderlying medical condition.

To use the marking tool (300) of FIG. 6A, the radiological technicianwould wind the patterned tape (302) to marked positions on the tape. Themarked positions indicate the length of tape necessary to completelyprevent any contamination from one use to the next. In other words, thelength of patterned tape (302) extending from the dispensing roller(310) to the take-up roller (311) is sufficiently long to ensurecomplete disposal of any portion of the patterned tape (302) that hasbeen previously exposed to another patient. For example and withoutlimiting the invention, one desirable length of tape for a single usemay extend between points (330) and (331) on FIG. 6A.

After rolling the patterned tape (302) to the appropriate markedpositions, the patterned tape (302) from the dispensing roller (310)passes in compressed engagement with the sponge (328) soaked withimaging material (13). The degree of compression between the patternedtape (302) and the sponge (328) is sufficient to soak completely theridges (303) that form the pattern on the tape (302). For a clear imageon the patient's skin, the degree of compression between the patternedtape (302) and the sponge (328) should minimize the amount of imagingmaterial dispersed on portions of the patterned tape (302) other thanthe design ridges (303). The amount of compression is controlled by aspring (327) connected to the body of the marking tool (300) and pushingagainst the sponge (328). The spring (327), therefore, biases the spongeto remain in contact with the patterned tape (302). By winding thetake-up roller (311), the dispensing roller (310) moves in conjunctionto pull the patterned tape (302) across the saturated sponge to allowthe absorbent ridges (303) to become fully engorged with imagingmaterial (13). Once the patterned tape (302) has been placed in properposition, the user presses the stamping body (318) against the patient'sskin. The stamping body (318) exerts sufficient compressive force on thepatterned tape (302) so that the ridges (303) expel the imaging material(13) onto the patient's skin in a desirable imaging pattern.

The embodiment of FIG. 6B operates according to the same principlesdiscussed in regard to FIG. 6A with the exception that FIG. 6B excludesthe take-up roller bar (311). Instead, according to the embodiment ofFIG. 6B, the marking tool (335) has appropriate cavities to house theimaging material reservoir (340), the sponge (343), and one dispensingroller (345) for a wound patterned tape (350). The patterned tape (350)has a desirable marking image formed by raised ridges (355). Thedifference in FIG. 6B is that the used patterned tape (350) can be tornoff by a razor assembly (360). In this embodiment, then, the user windsthe dispensing roller (345) or simply pulls on the free end (370) of thepatterned tape (350). Once the tape (350) is pulled to the appropriatelength, which may be marked as noted in regard to FIG. 6A, the user cantear off the excess or previously used tape for discarding. Thisembodiment also ensures that the raised ridges (355) are saturated withimaging material (13) by passing the ridges (355) on the patterned tape(350) across the sponge with sufficient compressive force between thesponge and the ridges (355) to allow for the ridges (355) to absorbimaging material. The user then presses the marking tool (335) againstthe patient's skin so that the ridges (355) release the imaging material(13) in a known pattern onto the skin.

The patterned tape (302, 350) of both FIGS. 6A and 6B includes marks toensure that a sufficient strip is discarded after each use to maintainsterility. In one embodiment, the patterned tape (302, 350) isperforated or includes other indicators to show the user how far to windthe tape or how long of a strip should be torn off prior to each use.This feature maximizes sterility and ensures that the patterned tape hasa sufficient amount of imaging material on the pattern for use.

Both embodiments shown in FIGS. 6A and 6B include a cap (365) to preventthe imaging solution from drying during periods of non-use. The cap(365) further enables a medical professional to cover the marking tool(300, 335) for conveniently carrying the device in a pocket withoutstaining. In one embodiment, the marking tool (300, 335) is of aconvenient shape and size to be portable in a shirt or jacket pocket.

FIGS. 7A to 7C show yet another embodiment of a marking tool useful forradiological purposes. The marking tool (400) is a hand-held instrumentwith a handle (410) at one end and a releasable marking head (420) atthe other end. The marking head (420) clips onto the handle (410) foruse and is removable by squeezing a release lever (412) on the top ofthe handle (410). The release lever (412) moves up and down to engageand disengage a corresponding engagement bevel (413) within the markinghead (420).

The marking head (420) includes multiple wicks (415) that are soaked inimaging material (13). To ensure that the marking head wicks (415)remain saturated during periods of storage, the marking head (420)includes imaging material reservoirs (422) in fluid communication witheach wick (415) to constantly supply imaging material to the wicks. FIG.7A shows only one possible configuration for the wicks, as any shape ordesired number of wicks will serve the same purpose. In fact, ifnecessary, the marking head could have just one wick that extends alongthe width of the marking head (420) or multiple designs on the edges ofeach wick (e.g., pointed wicks, rounded wicks, jagged wicks) for othermarking capabilities.

To ensure that the handle (410) is reusable, the marking heads may bestored and sold in the cartridge format of FIG. 7C. The cartridges (450)hold multiple marking heads (420) and seal the pre-soaked wicks (415) inan appropriate storage chamber (470) to maintain saturation. When onemarking head (420) is used up or dried out, then the lever (412) on thehandle (410) can release the marking head (420) for disposal. The userthen inserts the handle (410) into the neck of the marking head (420) sothat the handle lever (412) engages the bevel (413) inside the markinghead to retrieve the marking head (420) on the handle (410) for use. Atthis point, the radiology professional can use the wicks (415) on themarking head (420) to mark areas of interest on the patient's skin byapplying the imaging material in a desirable pattern.

The invention herein is sufficiently broad to account for various othermeans of applying the imaging material to skin stamp. Of course, atraditional ink pad could be used in conjunction with the marking toolby pressing the marking tool with a skin stamp thereon against a padsoaked with imaging material. In this embodiment, an entire stack ofskin stamps could be affixed to the bottom of the marking tool, oneattached to the other with a releasable adhesive. As the bottom stamp isused, that skin stamp is peeled away and the next skin stamp is madeavailable. To ensure complete sterility, the invention may include arelease layer, or peel away strip of paper, between each skin stamp.

In a marking tool according to this invention, the skin stamp comprisesa uniform design of raised ridges for placing a planned pattern ofimaging material directly onto a patient's skin. When that pattern isretained on the skin by drying or otherwise, the radiologist will have amapping diagram visible on the skin to plan medical intervention withneedles or other tools. When a medical imaging test is performed on thepatient, the imaging material design also shows up on the image toinform the radiologist even further in treating the patient. This isespecially useful in tracking imaging material position on the skin withthe imaging material that shows up on the medical image. For example, ifthe imaging material is placed on the skin in a series of visible hashmarks, those same marks will show up on the image to help theradiologist pinpoint better locations of medical interest by countingthe marks.

The invention herein is adaptable to multiple tools that implement thisnew method of indicating an examination area on a patient's medicalimages by distributing imaging material directly onto the patient'sskin. The descriptions of the embodiments noted above are in no waylimiting of the devices that could be used to form radiological markingsdirectly onto a patient's skin. Many different adaptations of thisinvention are available to ensure that a patient is marked with imagingmaterial forming patterns on the skin that are visible on the patientand visible on the medical images associated with that patient's medicalcondition. The invention is further intended for all medical purposes,including but not limited to treatment of the human population as wellas veterinarian applications.

Those having skill in the art will recognize that the invention may beembodied in many different types of hollow vessels with distributiontools for imaging material. For example, the invention described hereinmay be adjusted for use in a sterile environment such as an operatingroom or a clean-room portion of a laboratory. Accordingly, the inventionis not limited to the particular structures illustrated herein.

In the drawings and specification there has been set forth a preferredembodiment of the invention, and although specific terms have beenemployed, they are used in a generic and descriptive sense only and notfor purposes of limitation, the scope of the invention being furtherdefined in the claims.

1. A marking tool for distributing an imaging material directly onto apatient's skin to indicate an examination area on the patient's skin andassociated medical images, the marking tool comprising: a hollow vesselhaving an opening at one end; a closed chamber housing imaging materialtherein, wherein the closed chamber selectively releases the imagingmaterial into the hollow vessel upon bending the hollow vessel andwherein the imaging material is released onto the patient through theopening in the hollow vessel.
 2. A marking tool according to claim 1,wherein the opening in the hollow vessel is connected to an applicatorfor contacting the patient's skin.
 3. A marking tool according to claim1, wherein said hollow vessel is sufficiently pliable to bend withoutbreaking.
 4. A marking tool according to claim 3, wherein said closedchamber is sufficiently brittle to break and release imaging fluid intothe hollow vessel upon bending the hollow vessel.
 5. A marking toolaccording to claim 1, wherein said imaging material comprises barium. 6.A marking tool according to claim 1, wherein said imaging materialcomprises iodine.
 7. A marking tool according to claim 1, wherein saidimaging material comprises an oil-based compound.
 8. A marking toolaccording to claim 1, wherein said imaging material comprises a VitaminE based solution.
 9. A marking tool according to claim 1, wherein saidimaging material comprises gadolinium.
 10. A marking tool according toclaim 1, wherein said imaging material comprises a means forhighlighting an examination area on both a patient's skin and anassociated fluoroscopic image.
 11. A marking tool according to claim 1,wherein said imaging material comprises a means for highlighting anexamination area on a CT scan.
 12. A marking tool according to claim 1,wherein said imaging material comprises a means for creating a visiblemark that highlights an examination area on a patient's skin.
 13. Amarking tool according to claim 1, wherein said imaging materialcomprises a means for highlighting an examination area on an MRI.
 14. Amarking tool according to claim 1, wherein said imaging materialcomprises a means for highlighting an examination area on an X-Ray. 15.A marking tool for distributing an imaging material directly onto apatient's skin to indicate an examination area on the patient's medicalimages, comprising: a substantially hollow vessel for holding theimaging material; a tip at one end of said hollow vessel, said tipdefining an opening to the interior of said hollow vessel for controlleddistribution of said imaging material; and an imaging material fordistribution through said tip directly onto the patient's skin to markthe examination area.
 16. A marking tool according to claim 15, furthercomprising an applicator in fluid communication with said tip, whereinsaid imaging material travels through said applicator for distributiondirectly onto the patient's skin by contacting said applicator with theskin.
 17. A marking tool according to claim 15, wherein at least aportion of said vessel is formed of a material that is sufficientlypliable such that said imaging material can be squeezed from said vesselthrough said tip directly onto the patient's skin.
 18. A marking toolaccording to claim 15, wherein said vessel is sufficiently resilient toresist deformation after being subject to compressive force.
 19. Amarking tool according to claim 15, wherein said imaging material isselected from the group consisting of barium, iodine, and an oil basedcompound, and gadolinium.
 20. A marking tool according to claim 15,wherein said imaging material comprises a means for highlighting anexamination area on both a patient's skin and a medical image of thepatient.
 21. A marking tool according to claim 15, wherein said medicalimage is selected from the group consisting of an MRI, an X-Ray, a CTscan, and a fluoroscopic image.
 22. A marking tool according to claim15, wherein said imaging material comprises a composition selected fromthe group consisting of barium sulfate, bound iodine, flax seed oil,Vitamin E, and gadolinium.
 23. A marking tool for distributing animaging material directly onto a patient's skin in a design thatindicates an examination area on the patient's medical images,comprising: a substantially hollow vessel defining an opening at a firstend and a permeable bottom at a second end; a skin stamp adjacent saidpermeable bottom; an imaging material within said hollow vessel,wherein, said vessel releases said imaging material to flood said skinstamp through said permeable bottom.
 24. A marking tool according toclaim 23, wherein said skin stamp comprises a uniform design for placinga planned pattern of imaging material directly onto a patient's skin.25. A marking tool according to claim 23, wherein said skin stamp isremovable from said permeable bottom.
 26. A marking tool fordistributing an imaging material directly onto a patient's skin in adesign that indicates an examination area on the patient's medicalimages, comprising: a reservoir of imaging material in fluidcommunication with a patterned tape, wherein said patterned tapecomprises raised ridges for absorbing said imaging material; a stampingbody for pressing said patterned tape onto the patient's skin to releasesaid imaging material in a pattern on said patient's skin.
 27. A markingtool according to claim 26, further comprising a dispensing rollerwithin said stamping body for holding said tape.
 28. A marking toolaccording to claim 26, further comprising a take-up roller within saidstamping body.
 29. A marking tool according to claim 26, furthercomprising a sponge in fluid communication with said reservoir, whereinsaid sponge absorbs imaging material from said reservoir and distributessaid imaging material onto said tape.
 30. A marking tool fordistributing an imaging material directly onto a patient's skin in adesign that indicates an examination area on the patient's medicalimages, comprising: a handle; a marking head attached to said handle; atleast one applicator within said marking head for engaging a patient'sskin, wherein said applicator is soaked with imaging material anddistributes said imaging material onto the patient.